Catalent is a global, high growth, public company and leading partner for the pharmaceutical industry in the development and manufacturing of the new treatments for patients worldwide. Your talents, ideas, and passion is essential to our mission: to help people live better, healthier lives.
We are looking for a QUALITY SPECIALIST, this role would be responsible for supporting the centralised Customer Quality Technical Agreement (QTA) process in accordance with international regulatory, company and GMP standards (Good Manufacturing Practice).
You will work within a cross-site organisational team to support the issuance of new Quality Agreements, amendments to Quality Agreements and revision to Quality Agreements.
The Role
1. To create draft customer specific QTAs, revisions or amendments to QTAs, utilizing approved template(s).
2. To coordinate and communicate with the Business Development, Project Management and directly with the Customer and the Clinical Development & Supply (CDS) Catalent reviewers to facilitate the review and approval of multi-site or single site Customer QTAs.
3. To support tracking of QTA progress by entry of all new or change in status of the QTA document(s) within the shared tracking logs.
4. Write or revise Standard Operating Procedures (SOPs), SOP Work Instructions or SOP Forms
5. Support other CDS Clinical Global initiatives and other ad hoc duties as needed
6. Provide cross-functional support within the CDS Clinical Supply Global team and CDS Clinical Supply sites when applicable.
The Candidate
7. Bachelor’s degree in Business or Life Sciences preferred but not required
8. Relevant industry experience in the pharmaceutical industry. Quality or Regulatory areas preferred
9. Understanding of FDA and MHRA regulations pertaining to clinical packaging preferred
10. Understanding of pharmaceutical procedures
11. Candidate must be flexible, have well-developed organizational skills and have the ability to interact with all levels of management.
12. Strong computer, written and verbal communication skills.
13. Computer Skills – Experience with Microsoft Word and Excel and management of Documents.
14. A self-starter in nature, able to build relationships and work as a team.
15. High attention to detail
16. Strong written and verbal communication skills.
17. Must demonstrate proficient computer skills (Excel, Word, Access, and PowerPoint).
Why you should join Catalent:
18. Competitive Salary
19. Pension
20. Remote position – Monday to Friday
21. Opportunities to join Employee Resource groups and be involved in charity events
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
personal initiative. dynamic pace. meaningful work.
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Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.